# FDA 483 - FujiFilm Diosynth Biotechnologies U.S.A., Inc. - April 21, 2021

Source: https://www.keypedia.com/records/483/fujifilm-diosynth-biotechnologies-usa-inc/17d024ab-ac04-409b-9487-d3cc9484c5d4

> FDA 483 for FujiFilm Diosynth Biotechnologies U.S.A., Inc. on April 21, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: FujiFilm Diosynth Biotechnologies U.S.A., Inc.
- Inspection Date: 2021-04-21
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Fujifilm Diosynth Biotechnologies USA, Inc. in Morrisville, NC, identified multiple significant deficiencies in their drug substance manufacturing operations. The firm failed to implement adequate risk assessments for cross-contamination, maintain proper process monitoring, and ensure robust material management and cleaning procedures. Furthermore, issues were noted in discrepancy investigations, microbial control, data integrity, and overall facility and equipment maintenance.

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Company: https://www.keypedia.com/companies/fujifilm-diosynth-biotechnologies-usa-inc/44b7fa9f-848c-4e30-869e-12ddcfd848f8

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd